Yes, agreed, however, the risk for CUV is they will be labeled as one of the 'newcomers' in a hot market with a multitude of drugs who have a measly effect. Next to having a drug for a till now non curable symptom, due to the delays they now enter an increasingly crowded market with a lot of 'junk'. So, besides the difficulties with the authorities, they now have to battle and convince not only that the drugs work, they additionally have to convince (again) they are not junk because the opinion will be all drugs in that area are junk. The market area got stained. CUV has to show they are not jumping on a bandwagon. It is hard to get that opinion shed off. It could be competition is doing this on purpose, but that seems a bit too much tin foil hat for me, but well. Just saying.Part of the frustration for long term shareholders in clinuvel has been the endlessly dragged out approval, ethical procedures for everything cub does. Phase 3 EPP had to be repeated 3 times, ema decisions were delayed for almost two years, FDA cannot stop pondering over vitiligo trial protocols. Months after the first XP patient is treated their is no reported progress in the trial. VP is a big question mark still, a 6th indication waiting...for what? The cosmetics production partner cannot produce anything since the launch failure of May 2018. In the backdrop of this we are constantly bombarded with approvals and fast tracking of drugs that have seemingly no measurable positive effect of any sort.
Companies are multiplying market cap while cuv has a measly 18 k shares traded in a day with a 2 years sideways movement after FDA approval and this with triple approval and a constant business growth.
My experience with those fast boys is that eventually the market and clinical reality catches up.
1: it does not work and/or could be dangerous
2: nobody in the medical world will want to buy it for administration to patients
3: eventually patients or their family will find out and also resist ever using this drug
4: sp decline
No wonder people resign in protest. Who wants to have their name connected to failures like this?
For cuv and Scenesse the path is different.
Commercially/clinically proven worthy
Patients keep coming back.
Applications expanding gradually.
Makes me think that the FDA question to patients was possibly hinting at approved recell spray on skin for vitiligo treatment.
Absolutely, I don't know the outcome; and irrespective of the efficacy; that doesn't say a lot on how FDA will decide (see Biogen). However, the risk you mention was always there; what I mention is now added to the pile of risks. CUV is gaining foothold in EPP; if it is somehow flushed away because of an false imago being built around these drugs, you went from shit till worse. For the record; I fully believe in the product, and I don't see it as likely, but dirtier games have been played. And maybe I'm seeing issues which aren't dare, could be. I don't know.@Sherlock Isn't there also a substantial risk that Afamelanotide is lacking efficacy in treating Stroke, DNA repair and CNS diseases? I'm a bit surprised that "safety awareness" is considered to be the major risk. If there is any evidence that Afamelanotide is highly likely to work, please share these insights...I'll then take a loan and go all in CUV
Would big pharma have any interesting in some of the things Clinuvel has been doing recently though, such as manufacturing and the new labs in Singapore? I'd imagine big pharma wouldn't care much about that stuff since they have their own resources.@Klomp Certainly in a trading lull this week. US market is dead with virtually no activity. I’m starting to agree that being on NASDAQ would be beneficial. However, it may not even be of interest to management. The end game may be to just get a couple more indications approved, build up the pipeline and get a hefty buyout from big Pharma. I could see it happening in the next 3 years.
The same thought crossed my mind. CUV stated they really believe in vertical integration to control the whole process. If big Pharma comes in with a $5 or $10 billion buyout the cost of any manufacturing/new lab facilities CUV expended will be a drop in the bucket. Big Pharma could keep those new facilities and run a CUV subsidiary as a fairly independent operation or just close them and expense the costs.Would big pharma have any interesting in some of the things Clinuvel has been doing recently though, such as manufacturing and the new labs in Singapore? I'd imagine big pharma wouldn't care much about that stuff since they have their own resources.